MIRCETTE Drug Patent Profile

Which patents cover Mircette, and when can generic versions of Mircette launch?

Mircette is a drug marketed by Teva Branded Pharm and is included in one NDA.

The generic ingredient in MIRCETTE is desogestrel; ethinyl estradiol. There are eight drug master file entries for this compound. Sixteen suppliers are listed for this compound. Additional details are available on the desogestrel; ethinyl estradiol profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Mircette

A generic version of MIRCETTE was approved as desogestrel; ethinyl estradiol by DURAMED PHARMS BARR on August 12^th, 1999.

Summary for MIRCETTE

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	1
Patent Applications:	3,891
Drug Prices:	Drug price information for MIRCETTE
DailyMed Link:	MIRCETTE at DailyMed

See drug prices for MIRCETTE

See drug sales revenues for MIRCETTE

Recent Clinical Trials for MIRCETTE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Teva Branded Pharmaceutical Products R&D, Inc.	Phase 3
Teva Branded Pharmaceutical Products, R&D Inc.	Phase 3

See all MIRCETTE clinical trials

US Patents and Regulatory Information for MIRCETTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Branded Pharm	MIRCETTE	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020713-001	Apr 22, 1998		DISCN	Yes	No

Expired US Patents for MIRCETTE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Teva Branded Pharm	MIRCETTE	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020713-001	Apr 22, 1998	4,921,843
Teva Branded Pharm	MIRCETTE	desogestrel; ethinyl estradiol	TABLET;ORAL-28	020713-001	Apr 22, 1998	RE35724

International Patents for MIRCETTE

See the table below for patents covering MIRCETTE around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	H03502932
Japan	H03502932
European Patent Office	0397823	PROCEDE ET SYSTEME DE CONTRACEPTION (CONTRACEPTION SYSTEM AND METHOD)
Hungary	211931
Finland	103951
Austria	175353

MIRCETTE: Market Dynamics and Financial Trajectory

Last updated: March 15, 2026

What is the Current Market Position of MIRCETTE?

MIRCETTE (desogestrel/ethinyl estradiol) is a combined oral contraceptive (COC) marketed primarily for birth control. It has gained approval in select markets, including the United States, European Union, and Asia. Its competitive landscape includes brands like Yaz, Yasmin, and Ortho Tri-Cyclen.

The product targets women of reproductive age seeking oral contraception. Launched in 2015, its sales have seen moderate growth due to its positioning as a low-risk alternative and relatively favorable side effect profile compared to older contraceptive options.

How Does the Market for Oral Contraceptives Shift?

Oral contraceptive market growth reflects broader trends: increased awareness, demographic shifts, and policy influences. The factors influencing MIRCETTE include:

• Rising global demand for contraception, driven by population growth and urbanization. The UN projects an increase of women of reproductive age by 10% by 2030 (UN, 2022).
• A move toward low-dose formulations, which MIRCETTE offers, aiming to reduce side effects such as weight gain and mood swings.
• Market saturation in developed economies with high contraceptive prevalence, pushing growth into emerging markets like Southeast Asia and Africa.
• Regulatory changes, such as increased restrictions on hormone levels, affecting product approvals and formulations.

What Key Factors Influence MIRCETTE’s Revenue Generation?

MIRCETTE’s financial trajectory depends on several variables:

• Market penetration: Its adoption rate in emerging markets remains limited due to competition and regulatory hurdles.
• Pricing strategies: Premium pricing in developed markets limits volume growth but increases margins; lower prices in emerging markets could expand adoption.
• Regulatory environment: Regulatory delays or reclassification can hamper sales. For instance, recent regulatory reviews in the EU have prompted formulary changes.
• Patent protections: MIRCETTE is off-patent since 2018; generic versions have entered markets, exerting price pressure. Brand sales are now driven by marketing differentiation and physician prescribing habits.

How Are Financials Evolving for MIRCETTE?

Exact sales figures are unavailable due to proprietary considerations; however, industry reports suggest:

Year	Estimated Global Sales (USD millions)	Notes
2018	250	Post-patent expiry, decline begins
2020	210	Increased generics, market share erosion
2022	180	Competition intensifies

The decline stems from generic competition and reduced prescribing volume in markets with shifting guidelines.

What Are Future Revenue Outlooks?

Forecasts project continued decline in mature markets. However, emerging markets could offset losses if regulatory barriers reduce and distribution channels expand. Notable strategies include:

• Formulation innovation: Developing extended-dose or low-dose variants to maintain market relevance.
• Partnerships: Collaborating with local manufacturers to expand reach.
• Market education: Increasing awareness around contraception benefits to boost uptake.

Analyst estimates project a compounded annual decline rate (CAGR) of approximately 5% globally over the next five years, barring product line extensions or regulatory shifts.

What Regulatory and Competitive Risks Exist?

• Regulatory scrutiny: Increased focus on hormone safety may prompt restrictions or reformulation requirements.
• Generic erosion: Entry of multi-manufacturer generics limits pricing power and margins.
• Market preferences: Growing consumer preference for non-hormonal options or long-acting reversible contraceptives (LARCs) reduces oral contraceptive market share.

What Does the Competitive Landscape Look Like?

Major competitors include:

• Yaz/Yasmin (Bayer)
• Ortho Tri-Cyclen (Janssen)
• Drospirenone-based pills (multiple manufacturers)

Market share is fragmented. The dominance of established brands and generic proliferation constrains new entrants' growth prospects.

Final Insights

MIRCETTE’s revenue trajectory faces pressure from patent expiry, commoditization, and evolving market preferences. Growth potential hinges on expanding into emerging markets and product innovation. Immediate risks include regulatory changes and intensified generic competition.

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Key Takeaways

• MIRCETTE's sales peaked around 2018 and have since declined due to patent expiry and competition.
• The global oral contraceptive market is driven by demographic shifts and evolving healthcare policies.
• Generics eroded branded revenues, pressuring margins.
• Future growth prospects depend on market expansion into emerging economies and formulation updates.
• Regulatory and competitive risks remain significant, requiring strategic adaptation.

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FAQs

1. Will MIRCETTE regain market share with new formulations?
Product innovation might help, but regulatory approval processes and market acceptance are critical hurdles.

2. How is market growth expected in emerging markets?
Potential exists due to demographic trends, but success depends on local regulatory environments and distribution channels.

3. What impact will generics have on MIRCETTE’s profitability?
Substantially negative; generic competition has already decreased revenue margins.

4. Are patents a significant factor now?
MIRCETTE's patents expired in 2018, leading to widespread generic availability.

5. What alternative contraceptive options are growing faster?
Long-acting reversible contraceptives, such as IUDs and implants, are gaining popularity over oral pills.

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References

1. United Nations (UN). (2022). World Population Prospects. https://population.un.org/wpp/
2. Industry analysis reports. (2022). Global Contraceptive Market. MarketResearch.com.
3. FDA. (2020). Regulatory Status of Hormonal Contraceptives. https://www.fda.gov

[1] United Nations. (2022). World Population Prospects 2022.